Edentulous surgical guide

ABSTRACT

A dental surgical drill guide assembly and method includes a surgical guide housing and a base frame that fits to both gum tissue and one or multiple small areas of jawbone. The apparatus may be configured to accurately place dental implants according to planned positions. Such apparatus may increase the stability of the surgical guide by clasping and/or contacting the jawbone, while improving the overall fit and minimizing the need of invasive surgery and flapping by also clasping and/or contacting selected areas of the gum tissue at the same time. Self-locking alignment members aid in easy removal, and re-installation, of the surgical guide housing to the base frame.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 13/621,146, filed on Sep. 15, 2012 (U.S. Pat. No.9,504,533), which claims priority to U.S. Provisional Application Ser.No. 61/535,698, filed Sep. 16, 2011. The contents both of which arehereby expressly incorporated by reference in their entirety.

FIELD OF THE INVENTION

An improved dental implant method and apparatus is disclosed, and, moreparticularly, a surgical guide that can be fit to a patient's jawbone.

BACKGROUND AND SUMMARY OF THE INVENTION

Dental implants are commonly used in today's dental practices to supportvarious prostheses. Challenges to the successful placement of dentalimplants include poor bone quality and various hidden anatomicalfeatures such as nerves, roots, and sinus cavities. Surgical preplanningmethods and drill guide apparatuses may be used to better address thesechallenges. With edentulous cases, surgical drill guide apparatuses canbe divided into two categories: bone borne surgical drill guides and gumtissue borne surgical guides.

Bone borne surgical drill guides are made to fit on a patient's jawbone,and can be made from either a digital jawbone model or rapid-prototypedphysical jawbone model of the patient. The primary problem with boneborne surgical guides is the invasiveness of the amount of flapping ofthe gum tissue that the surgeon has to create in order for the guide tofit correctly on the patient jawbone. The amount of flapping requiredincreases the likelihood of surgical risks and complications, includingblood loss, infection, healing problems, and overall pain experienced bythe patient. Flapping and suturing also requires a great deal ofsurgical time. In addition to the problems associated with the surgicalprocedure, difficulties may also arise when the jawbone has low density,which happens often with Maxilla bones in posterior region. Low bonedensity makes it difficult to define the contour of the bone in CTimages, which may cause the bone borne surgical drill guide to fitpoorly. Thus, the use of bone borne surgical drill guides has drawbacksand it would be preferred to overcome their associated problems.

Gum tissue borne surgical drill guides are made to fit on top of apatient's gum tissue without the need for any surgical incisions tostabilize the guide. In order to create this type of surgical guide, thesurface scan data of the gum tissue and the tomography data of thejawbone need to be accurately aligned and mapped. For this purpose,usually an imaging template is worn by the patient during tomographyscanning, and the fiducial markers on the device are used for alignmentof the different data sets. While this method is less surgicallyinvasive than the bone borne method, gum tissue borne surgical guideslack stability. Gum tissue is in a constant state of movement and drift,and is also pliable with pressure. Moreover, certain health conditionsand even the intake of certain foods make gum tissue more prone toswelling. These conditions may prevent the accurate positioning of thedevice in the mouth. Here, even if the surgeon uses anchor screws, theymay be securing the device in the wrong position. This type of surgicaldrill guide sacrifices accuracy for convenience. Thus, it would bepreferred to overcome these problems.

Accordingly, it would be desirable to provide a stable and accuratesurgical drill guide apparatus that requires only minimum flapping andfits to both gum tissue and one or multiple small areas of jawbone. Suchapparatus may increase the stability of the surgical guide by claspingand/or contacting the jawbone, while improving the overall fit andminimizing the need of flapping by also clasping and/or contactingselected areas of the gum tissue at the same time. The apparatus may beconfigured to accurately place dental implants according to the plannedpositions.

It would also be preferable to provide an apparatus that may be customdesigned to suit the unique anatomical features of each individual. Thedevice may be designed on a digital anatomical jawbone model withaccurately mapped and aligned gum tissue information, and may be rapidprototyped or milled as a drill guide frame or frame set. Also, theapparatus may be made by hand on the rapid prototyped or CNC milledphysical anatomical model that partially exposes the jawbone structure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a top view of an upper jaw anatomical diagnostic model withgum tissue and a partially exposed bone structure;

FIG. 1B is a perspective front view of a lower jaw anatomical diagnosticmodel with gum tissue and a partially exposed bone structure;

FIG. 1C is a perspective front view of a lower jawbone digital image anda gum tissue image which are about to be aligned;

FIG. 1D is a perspective front view of a lower jaw bone digital imagealigned with the gum tissue digital image;

FIG. 2A is a top view of an exemplary base frame for an upper jaw on adiagnostic model with gum tissue and a partially exposed bone structure;

FIG. 2B is a side view of the exemplary base frame for the upper jaw onFIG. 2A diagnostic model;

FIG. 2C is a bottom view of the exemplary base frame for the upper jawshown in FIG. 2A;

FIG. 2D is a top view of an exemplary base frame for a lower jaw on adiagnostic anatomical model with gum tissue and a partially exposed bonestructure;

FIG. 2E is a perspective front view of the exemplary base frame for thelower jaw on the same anatomical diagnostic model shown in FIG. 2D;

FIG. 2F is a perspective view of an exemplary base frame for the upperjaw;

FIG. 3A is a side view of the exemplary drill guide housing frame forthe upper jaw about to be attached to the exemplary base frame on theanatomical model;

FIG. 3B is a top view of the FIG. 3A drill guide housing frame, withskirted area on the base frame and the physical anatomical diagnosticmodel;

FIG. 3C is a side view of the FIG. 3A drill guide housing frame, with ahand piece drilling holes into the skirted areas;

FIG. 3D is a top view of the FIG. 3A exemplary drill guide housingframe, with holes that correspond with planned osteotomies on thephysical anatomical diagnostic model;

FIG. 3E is a side view of the FIG. 3D physical anatomical diagnosticmodel, with positioning pins and drill guide bushings placed into theplanned osteotomies through the holes on the skirt portion of the drillguide housing frame;

FIG. 4A is a top view of an exemplary drill guide section for the upperjaw placed on the base frame and the physical anatomical diagnosticmodel;

FIG. 4B is a perspective view of the FIG. 4A anatomical diagnostic modelwith base frame and positioning pins, showing intersecting osteotomyangulations;

FIG. 4C is a top view of an exemplary interchangeable additional drillguide section with a tube surgical drill guide bushing;

FIG. 4D is a top view of an exemplary surgical drill guide section forthe lower jaw placed on the base frame and the physical diagnosticanatomical model;

FIG. 5 is a perspective view of an exemplary modified denture duplicateattachment for an upper jaw attached to a base frame;

FIG. 6A is a perspective front view of an exemplary anatomicaldiagnostic model with a partially exposed lower jaw bone beforeadjustment;

FIG. 6B is a perspective front view of the exemplary anatomicaldiagnostic model with a partially exposed modified lower jaw bone withplanned osteotomies;

FIG. 6C is a perspective front view of an exemplary base frame on thediagnostic anatomical model;

FIG. 6D is a perspective front view of an exemplary drill guide sectionplaced on the base frame and the anatomical diagnostic model;

FIG. 7 is a perspective view of an exemplary one piece drill guide on aphysical anatomical diagnostic model;

FIG. 8 is an exploded perspective view of the FIG. 6D drill guideassembly;

FIG. 9 is an exploded perspective view of another exemplary drill guideassembly;

FIG. 10 is the FIG. 9 drill guide assembly in assembled form;

FIG. 11 is a bottom perspective exploded view of the FIG. 8 assembly;

FIG. 12 is the base frame of the FIG. 9 drill guide assembly shownpositioned within the mouth of a patient.

FIG. 13 is a diagram of the edentulous surgical drill guidemanufacturing process for a model based implant placement planning;

FIG. 14 is a diagram of the edentulous surgical drill guidemanufacturing process for a digital implant placement planning; and

FIG. 15 is a diagram of how to utilize the edentulous surgical drillguide during the surgery.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the discussion that follows and also to the drawings,illustrative approaches are shown in detail. Although the drawingsrepresent some possible approaches, the drawings are not necessarily toscale and certain features may be exaggerated, removed, or partiallysectioned to better illustrate and explain the present disclosure.Further, the descriptions set forth herein are not intended to beexhaustive or otherwise limit or restrict the claims to the preciseforms and configurations shown in the drawings and disclosed in thefollowing detailed description.

FIGS. 1A and 1B illustrate patient specific digital or physical dentalanatomical diagnostic models 100 and 101 that expose the partial upperjawbone bone structures 103 and a lower jawbone 104 at the surgicalsites and the areas of interest. In areas where the bone structures arenot exposed, the model has gum tissue surface structures 102. As inFIGS. 1A and 1B, these gum tissue surface structures 102 usually appeartowards the distal end of the posterior regions and the palatal area ofthe upper jaws.

FIGS. 1C and 1D depict a digital image of a lower jawbone 104 and adigital image of the gum tissue surface structures 102 positionedrelative to one another, from which diagnostic anatomical models like 1Aand 1B are created.

The bone structure data can be obtained by tomography imaging devicessuch as CT and CB CT, and may be exported as a file format, such as STL,suitable for reverse engineering and 3D imaging. Then the data file canbe accurately aligned with the surface scan data of the gum tissue 102obtained by devices such as laser and optical scanners by means ofmatching fiducial markers on the imaging apparatus that the patientwears during the tomography scan to the markers' positional informationon the surface scan data. If the bottom of the apparatus represents thepatient's gum tissue surface, the image of the patient's gum surface canalso be obtained by scanning the imaging apparatus alone using atomography device. In this case, these two CT data files can be alignedby the fiducial marker location(s) after each structure is thresholdedand is exported as a proper file format for modeling. If a radio opaqueduplicated denture is used as an imaging apparatus, the bone structuredata and the gum surface data can be obtained with a single CT scan ofthe patient with the imaging apparatus in place. After the necessarystructures are properly aligned in a file format suitable for 3Dmodeling, the data files can be combined and used to design a digitalanatomical diagnostic model with a partially exposed bone structure inthe area of the surgical site.

The osteotomies of simulated dental implant placements 105 may becreated either digitally on the digital anatomical diagnostic model ormanually on the rapid-prototyped physical anatomical diagnostic model.Then a drill guide apparatus may be designed on this type of digitalanatomical diagnostic model so that it will accommodate drill guidebushings or holes which guide the surgical drill according to theplanned osteotomies either on the digital anatomical diagnostic model orthe physical anatomical diagnostic model. Alternatively, the wholeapparatus can be designed manually on this type of physical anatomicaldiagnostic model with dental materials such as, but not limited to,light cured composite, cold cured resin or acrylic, or thermoplastic.

FIGS. 2A-E are exemplary designs of a base frame 200 for an upper jaw(FIGS. 2A-2C) and a lower jaw (FIGS. 2D & 2E). The base frame 200 may bemade of a transparent or semi-transparent resin or other compositematerial that gives the surgeon maximum visibility of the surgical site,but it may also be made of a colored resin and other composite materialor metal that provides the base frame 200 with enough rigidity forstability and the right amount of flexibility in clasping areas. Inorder to obtain rigidity and flexibility in different areas, the frame200 may be designed to have thick areas and thin areas accordinglywithin the frame. Overall however, the base frame can be more flexiblethan one piece surgical guide since the surgical drill guide sectionplaced on top of it can solidify the whole drill guide assembly and theflexibility allows the device to clasp on to the undercut easily. Thebase frame 200 is shown positioned on top of the upper jawbone structure103. A plurality of osteotomies of simulated dental implant placements105 are shown about the periphery of the upper jawbone structure 103. Ahandle 203 is secured towards a forward portion of the base frame 200which is used to aid in the maneuverability of the base frame 200.Interlocking connectors 204 are firmly mounted to, or formed partthereof, the base frame 200, and provide guides for the surgical drillguide housing frame 300 to connect thereto. The arrows 20 depictpotential pressure impinging points for the drill guide housing frame300 to impinge upon.

FIG. 2D shows a base frame 200 on the type of anatomical modelsexplained above, and gum tissue contact portions 201 are placed on thegum tissue areas of the model. Although this portion may have broad areacontacts with the gum tissue 102, it may also have strategically placedsmaller spot contact areas 205 as shown in FIG. 2C. In some designs,certain areas of gum tissue contact portion can be used to placetemporary anchors through the gum tissue into the patient jawbone bysmall screws, pins or other fastening devices.

The surgical device 200 may also have one or more clasping lateralcontacts 202 (See FIGS. 2B-2E) that may simply contact the lateral wallof the exposed jawbone 103 and 104 or engage its undercut. As shown inone exemplary design of the base plate 200 for a lower jaw 104 (FIGS. 2D& 2E), clasping lateral contacts 202 may be connected to the gum tissuecontact portion 201 by stabilizing/clasping arms 207 that may or may nothave contact with the oral structure. The stabilizing/clasping arms 207extend out from a base frame 200 and/or drill guide housing frame 300which may be turn into a drill guide housing section 400 with drillguide bushings. When the frame is placed on the oral structure oranatomical diagnostic model, the stabilizing/clasping arms 207 slightlyflex out and then clasp securely onto the oral structure 104. Althoughthe stabilizing/clasping arms 207 are illustrated as peninsulas thatextend out of the tissue contact area, the stabilizing/clasping arms 207may be continuously connected to the tissue area like in the exemplarybase frame 200 shown in FIG. 2F. Clasping lateral contact area 202 mayalso be used for placing a temporary anchor directly into the jawbone104 if the patient's oral structure does not allow the device to haveenough retention.

Similar to the clasping lateral contacts 202, one or moreocclusal/lateral stabilizing rests 206 (FIG. 2D) may be strategicallyplaced to contact the jawbone 104 to work along with the gum tissuecontact portion 201 and the clasping lateral contact 202 in order forthe device 202 to be securely positioned inside of the patient's oralstructure (See FIG. 12). This section may also be connected to the gumtissue contact portion 201 by at least one stabilizing/clasping arm 207.

The arrows on FIGS. 2A, 2E and 6C indicate the direction of force 20applied from each contact point to the oral structure, and show howstabilizing/clasping arms 207 help fixate the device 200 in place.

Although it is not illustrated, due to a particular shape of the jawbone103, 104, the base frame 200 may be designed to have only tissuecontacts without any jawbone contact and to have a separate detachablyattachable part that snaps onto it and engage the jawbone.Alternatively, this bone clasping part can be a latch connected to thebase frame 200 by a hinge.

The base frame 200 may also include a handle 203 on FIGS. 2A-2C that maybe used when removing the device from the oral structure, and aninterlocking connector 204 (FIG. 2A, 2B, 2D, 2E) that securely connectsthe base frame 200 to a surgical drill guide housing frame 300 (FIGS.3A-3E, and FIGS. 4A, & 4C). The handle 203 may also be ahandle/connector, a part of which works as a male interlockingconnector. FIG. 2F illustrates the base frame 200 having connectors 204that are secured to the upper service thereof. Stabilizing arms 207 arepositioned around its outer periphery with openings 208 being positionedadjacent thereto.

FIG. 3A illustrates an exemplary drill guide housing frame 300configured to be disposed on the base frame 200, which collectively forman assembly 310. Material requirements for the drill guide housing frame300 are same as the specifications for the base frame 200. The drillguide housing frame 300 may securely snap onto the base frame 200 by theinterlocking connectors 204 (FIGS. 2A, 2C, 2D, 2E) and the connectorreceptors 304 (FIG. 3B), also by the handle 203 and handle/connectorreceptors 303 (FIGS. 3A-3D), along with various stabilizing rests and/orclasping contact areas between the two devices 200, 300. As illustrated,the interlocking connectors 204 on the base frame 200 may be maleconnectors with strategically placed slight undercuts, and the connectorreceptors 302 and 303 on the drill guide housing frame 300 may be femaleconnectors. However, various types of different connector mechanisms canbe used for this purpose. Similar to the handle/connector 203 on thebase frame 200, the handle/connector receptor 303 may be used whenremoving the device from the base frame 200, and it may also be used asa receptor for the handle/connector 203. Similar to the contactpoints/areas of the base frame to the oral structure, the drill guidehousing frame 300 may have clasping or resting contact points/areas tothe base frame 200 besides the connectors. These contact points/areasmay be strategically placed to work together along with the connectorsnot only to ensure a secure fit of the part to the base frame 200 butalso to lock in the entire device (the base frame and the drill guidehousing section) onto the oral structure by adding an extra layer ofthickness and applying more clasping force. The base frame 200 and thesurgical drill guide housing 300 may be designed to work together tomake the assembly 310 set snugly fit onto the oral structure 100 and yethave great rigidity so that it is very stable in the patient's mouth aswell as on the physical anatomical diagnostic model. Although notillustrated, the frames may be fastened together using any othersuitable fasteners including, but not limited to, screws, pins andlatches.

The holes 304 on the connector receptors 302 and handle/connectorreceptor 303 shown on FIGS. 3B and 3D are liquid escape holes 304 thatallow excess moisture and debris to escape so that they will not betrapped in-between the devices 200 and 300. It should be noted that theliquid escape holes 304 can be created in different areas of the drillguide housing frame 300. The larger opening holes 305 in the middle ofthe devices 300 and 401 in FIGS. 4A and 4C are clearance openings forfastening anchor devises such as screws and pins that are used to fastenthe base frame 200 onto the jawbones 103 and 104 without engaging withthe drill guide housing frame 300. However, the larger opening holes 305may also be used as liquid escape holes 304.

Unlike the handles 203 and 303, other exemplary handles may not have aconnecting function. The handles may be on either one or both of thebase frame 200 and the drill guide housing frame 300, and there may bemore than one handle 203 and 303 on both frames. Moreover, the handleson the base frame 200 and the drill guide housing frame 300 can worktogether as a combination handle unit. Ideally, the combination handleunit is designed to leave a small space at least in a certain areabetween the devices' handles so that a hand instrument or other types oftools can be inserted into the space to pry the frames apart. Also,similar spaces 601 for the instrument may be created between the framesin other areas to make the separation of the frame easier. See FIGS. 6D,8 and 11.

Optionally, the device may also feature skirted areas 301 (FIG. 3B) overthe intended surgical site(s). This feature may be useful when thesurgeon plans the osteotomies 105 on a physical anatomical model and thedevice is rapid prototyped or CNC milled from the design created on thedigital anatomical model. The skirted areas may be a thin shell thatextends from the device 300 and covers the intended surgical site(s).The purpose of this feature is to provide base structure for thesurgical drill guide site(s). When the osteotomies are planned on arapid-prototyped or milled physical anatomical model, the implantpositions and angulations are unknown at the time of manufacturing ofthe surgical drill guide frame or frame set. By having a thin skirtedarea 301 over the intended implant site as a base structure, it may beeasier to prepare the surgical drill guide site(s) on the device 300.Also, the skirted area 301 can be made so that the top surface or thebottom surface of the section represents the patient's gum tissue 102.It can also be made so that the bottom surface of the section sits ontop of the bone, a certain distance away from the bone below or abovethe gum tissue. By going through the procedure that is shown on FIG. 3C,the holes 306 that correspond with the planned osteotomies 308 will becreated on the skirt as shown on FIG. 3D. Drill 306 is used to createthe holes 306. When the surgical drill guide sites are prepared on thephysical anatomical model 100, positioning pins 308 may be used to setthe angulations of the osteotomies and to position the surgical drillguide parts 309 as shown in FIG. 3E.

FIG. 4A illustrates an exemplary surgical drill guide section 400 thatwas trimmed after surgical drill guide sites are prepared so that thedevice 400 may provide improved surgical site visibility and goodfacility for irrigation. Optionally, metal or ceramic tube type 309 a oropen-face type 309 b surgical drill guide bushings can be attached tothe device 400, but the device may not have any added parts to the drillguide site. If the implant placement is digitally planned on the digitalanatomical model prior to the model manufacturing, the drill guidehousing frame 300 can be digitally designed like this illustration,without any skirted area 301, so that the drill guide bushings 309 a and309 b can be attached to the device 400 right after manufacturing.Another exemplary surgical drill guide section 400 shown in FIG. 4D fora lower jawbone 101 snapped on to the base frame 200 illustrates thespace 105 between jawbone surface 103 and the bottom of the drill guidehousing frame 400 over the surgical site, which may be preferred bysurgeons for the better irrigation. However, as previously described,the bottom surface of the drill guide housing frame may be set at adifferent height.

FIG. 5 illustrates the modified duplicated denture appliance 500attached to the base frame 200. One way of creating this appliance is toscan the patient's denture or duplicated denture surfaces, align thedata to the anatomical model, and modify it to fit on the base frame200. This appliance 500 may have features such as connector receptors302, irrigation holes 304, and openings for fastening anchor devices 304just like a surgical drill guide housing frame 300. This appliance 500may be used to verify the position of the base frame or the single piecesurgical guide with patient's bite. Other examples of attachmentsinclude, but are not limited to, an implant pick up impression tray, animplant transfer jig tray, and a bone adjustment jig.

Advantages of the drill guide assembly 310 having the base frame 200 andthe drill guide housing frame 300 may include: 1) Interchangeablemultiple guide frames 300 can be used during the surgery while the baseframe 200 can be securely positioned in the patient oral structure; 2)If, for any reason, the doctor changes the positioning of one or more ofthe implants from the original plan, and cannot use the surgical drillguide for those particular site(s), or needs to work on the bone, he/shecan temporarily remove the drill guide housing frame 300 from the baseframe 200 without disturbing the position of the base frame 200; 3)Various types of additional attachments can be placed on the base plate200 without the drill guide parts covering the surgical sites. The drillguide assembly 310 is especially beneficial when the base frame needs tobe temporarily anchored to the patient's jawbone.

More than one surgical drill guide section 400 may be needed in order toaccommodate a surgery's specific needs. As illustrated with thepositioning pins 308 a and 308 b in FIG. 4B, two of the intendedosteotomies 105 a and 105 b are very close to each other and haveintersecting positioning angulations. In this case, a second surgicaldrill guide section, 401 in FIG. 4C may be created for one of theplanned osteotomies 105 a. This type of additional surgical guidesection 401 is detachably attachable to the base frame 200 and isinterchangeable with the first surgical drill guide section 400.Alternatively, smaller parts that house the surgical drill guidebushings 309 or drill guide holes for specific implant placement sitesmay be attached to the first surgical drill guide section 400. Althoughit is not illustrated, another benefit for having additional surgicaldrill guide section 401 is to accommodate larger size surgical drillguide bushings, 309 a and 309 b that are subsequently used for finishdrilling osteotomies 105.

FIGS. 6A-6D represent a situation in which the doctor decides to reducethe jawbone prior to implant placement. FIG. 6A is an anatomicaldiagnostic model of a lower jaw 101 which shows a gum tissue portion 102and a partially exposed bone structure 104. The doctor may wish tomodify the bone 104 b prior to the implant placement as in FIG. 6B. Inthis case, the base frame 200 (FIG. 6C) may be designed according to thedoctor's specification either on the digital model or the physicalanatomical diagnostic model so that it can be used as a bone reductionjig. FIG. 6C illustrates a base frame (200) on an anatomical diagnosticmodel with a modified lower jawbone 104. A drill guide section 400 FIG.6D may be designed on top of the base frame 200 to be used for implantplacement.

Various types of additional detachably attachable appliances can beadded to the surgical drill guide 400. One example of an additionalappliance is a modified duplicated denture attachment 500.

It will be appreciated that the surgical drill guide can be manufacturedas single piece 700 (FIG. 7) that contacts both gum tissue and exposedbone. Single piece apparatus 700 has combined functions of both baseframe 200 and the surgical drill guide section 300. The device may haveall or some of the features described above, or it may include differenttypes of attachments. Lateral contacts 202 on the forward edge areconnected to an arm 207, which may be a part of the single piece guide700.

FIG. 8 is an exploded view of a two part surgical drill guide assembly401 that is shown in FIG. 6D. The assembly consists of the surgicaldrill guide section 400 and the interlocking base 200. Collectively, thedrill guide section 400 and base 200 can be snapped together andstrategically placed relative to the lower jaw 101 which, in thisinstance, is a physical diagnostic anatomical model of a lower jaw for ahuman being. The base 200 has a base member 203 at a rearward portion, afirst outwardly extending clasping or stabilizing arm 207, and a secondarm 206 that extends from the base member 203. The arms have flattenedportions and are resilient for placing a force on a jaw. The base 200 isoperable to be received on the lower jaw 101 and located relative to theinterior 250 and exterior 252 surfaces of the lower jaw 101. Inparticular, the base 200 further has lateral contacts 202 at internallocations, which are strategically located to impinge upon exteriorsurface 252 of the lower jaw 101. For example, lateral contact 202 a isoperable to impinge upon exterior contact 252 a. Likewise, lateralcontact 202 b is designed to strategically impinge upon contact surface252 b in two locations relative to the exterior surface 252 of the lowerjaw 101. Likewise, lateral contact 202 c is located on an outwardlyextending portion of the base frame 200, and is operable to engageinterior surface 250 c of the lower jaw 101. These contact points, andothers, are designed to impinge forces 20 (See FIGS. 2A, 2E and 6C) foraiding and positioning, the base frame 200 relative to the lower jaw101.

Once the base frame 200 has been positioned relative to the lower jaw101, the surgical drill guide section of 400 has receptacles that aresnapped to interlocking connectors 204 that, in the exemplary model, arepositioned at three locations about the base frame 200. It will beappreciated that more, or fewer, interlocking connectors 204 can beprovided. The locking fit between the interlocking connectors 204 andthe corresponding female receptacles that are on the underneath side ofthe surgical drill guide section 400, create a snap-fit type connection.This snap-fit configuration provides for ease of separability of thedrill guide section 400 and the base frame 200, as well as provides aself-centering locating arrangement for making sure the assembly 401 isproperly fit together. The drill guide section 400 includes a flattenedcenter portion 303 that has a plurality of bushings 309 a or 309 bextending through the flattened portion. The drill guide section 400further may have water escape holes 304, along with the open face drillguide bushings 309 b, as well as a separation feature or openings 601 atthree locations, which aid in separating the drill guide section 400 andthe base frame 200. The openings 601 are sufficient to allow a device,for example a dental instrument, to be inserted between the drill guidesection 400 and the base frame 200, so as to allow ease of separation ofthe two components.

The open face drill guide bushings 309 b provide a guide mechanism forreceiving positioning pins 308. The bushings are preferably made ofmetal and they are anchored in the guide section 400. The positioningpins 308 may be made of metal or hard plastic and are placed into theplanned osteotomies within the lower jaw anatomical diagnostic model 101and are configured to receive the bushings 309 b, which helps align thedrill guide 400 relative to the jaw 101. At the surgery, drill guidebushings guide the drills to create osteotomies for implant placement.

FIG. 9 illustrates another exemplary drill guide assembly 401 includinga drill guide section 400 and a base frame 204 b, which also works as abone reduction jig. The assembly 401 can be positioned relative toexposed bone area 104 b of a lower jaw 101, which, in this visual, is adiagnostic anatomical lower jaw model. This particular lower jaw model101 includes extracted teeth sockets 110, which can be either recentlyextracted teeth or digitally simulated planned teeth extraction, a gumtissue area 102, and nerve endings 112. The base frame 200 b hasinterlocking connectors 204 formed on the upper surface of the baseframe 200 b that can be integrally molded to the base frame 200 b.Lateral contacts 202 a and 202 b are positioned about an interiorsurface of the clasping arm 207 and form pressure points for impingingupon exterior surface 252 of the lower jaw 101 at points 252 a, and 252c, respectively.

The surgical drill guide section 400 is shown ready to be positioned andconnected to the base frame 200 b. Drill guide bushings 309 a areprovided within holes for receiving positioning pins 308. An opening 601is provided to help in separating the drill guide section 400 from thebase frame 200 b.

FIG. 10 illustrates the FIG. 9 surgical drill guide assembly 401 in anassembled condition. The drill guide 400 is shown in place relative tothe base frame 200 b which in turn, is positioned relative to the lowerjaw 101.

FIG. 11 illustrates a bottom perspective view of the FIG. 6 surgicaldrill guide assembly 401. From this perspective, the underside of thebase frame 200 and the drill guide section 400 can be more readilyobserved. The lower jaw 101 is shown with gum tissue 102. The Base frame200 has scalloped or saddle shaped tissue contact portions 220 that arereceived by the gum tissue areas 102 of the lower jaw 101. The claspingarm 207 has impinging areas 202 a and 202 b that impinge upon surfaces252 a and 252 b, respectively, of the jaw 101. Likewise, impingingsurface 202 c impinges upon corresponding internal surface 250 c of thejaw 101 so as to provide an inwardly impinging force 20 as previouslydepicted in FIG. 6C.

The surgical drill guide section 400 has receptacles on the undersidesurface 452 that are operable to lockingly engage with interlockingconnectors 204 (FIG. 9) of the base frame 200. Openings 601 provide agap between the surgical drill guide 400 and the base frame 200 so as toallow for ease of separation between these two components. The recess450 is slightly larger in physical configuration than the interlockingconnector 204. The interlocking connector 204 is sufficiently resilient,as is the receptacle 450, so as to provide a positive snap-fit lockingconfiguration between the components 400 and 200. Once together, aninterlocked assembly 401 is created, which can be easily alignedrelative to the jaw 101.

FIG. 12 illustrates a perspective view of the base frame 200, which isfunctioning here as a bone reduction jig, being positioned relative tothe lower jaw 101 in the context of a mouth 150. It depicts the lowerjawbone having a shaved section 152 according to the clasping armportion of the base frame 200. Extracted teeth sockets 154 are presentand depict the location of the extracted teeth. An interlockingconnector 204 is shown and is operable and ready to receive the surgicaldrill guide section 400 (not shown).

FIG. 13 and FIG. 14 show different manufacturing methods of using anedentulous surgical drill guide or assembly 401. FIG. 13 illustrates amodel based implant placement planning method 800 and FIG. 9 illustratesa digital implant placement planning method 900. Both methods start witha digital anatomical diagnostic model, with partially exposed jawbone101 in the area of interest, in a file format such as STL that allowsreverse engineering and 3D modeling 801 and 901. The digital anatomicaldiagnostic model 801 can be obtained by accurately aligning the surfacescan data of the patient's mouth or dental cast and the tomography scandata that is volume rendered and converted to a compatible file format.Since all the devices are patient specific, the design and features ofthe apparatus is planned according to the patient's oral structure, bonecondition, and the surgical needs. Although the apparatus can be createdas one single surgical guide as described in the diagram in FIG. 7, thesame or similar procedure may be applied when using a multiple pieceguide.

In both methods, a technician digitally designs the base frame 200, andthe drill guide housing frame 300, along with additional frames andattachments, if any, using reverse engineering software program such asGeomagic, Radidform, and 3 Matics, optionally combined with 3D modelingsoftware such as Rhinoceros 3D and Solidworks (See steps 802, 902, 803and 903). The base frame 200 (FIG. 2) can be designed first on thedigital model with partially exposed bone just in the area of thesurgical site 802 and 903 and then the drill guide housing frame section300 (FIG. 3) can be designed on both the digital anatomical diagnosticmodel and the base frame (802 and 902). By doing so, the surgical guidecan be designed to obtain better fit and stability, because 1) it avoidsbone contact in the areas where the density of the bone is too close tothat of the soft tissue for its contour to be accurately defined in theCT images when the bone is porous, and 2) it also clasps onto rigid boneareas instead of contacting the malleable tissue surface alone.Subsequently, if additional frames or attachments are needed, they canbe designed to fit on the base frame 200 and/or the surgical drill guidehousing frame 300 according to the part's function 803 and 903. Some ofthe features and functions of the apparatus are the same or similar forthe model based implant placement planning or the digital implantplacement planning. However, several differences may be found infeatures and methods between for these two situations.

FIG. 13 illustrates a workflow 800 of a model based surgical planning.When the implant placement is planned on an aligned physical anatomicaldiagnostic model 812 created by rapid prototyping 811 the digital model801, the technician needs to design the drill guide housing frame orhousing frame section 300 on the digital anatomical diagnostic modelwithout knowing the exact plan of implants' positioning. Naturally, thedevice is designed as a base structure of the surgical guide that willbe assembled manually on the physical anatomical model. Thus, the deviceoften has the skirted area 301 (FIG. 3B) that extends over the intendedsite so that it is easier for the clinician or technician to assemblethe surgical drill guide later on a physical anatomical diagnostic model(See steps 806-809). Similarly, other special parts that work on thephysical model may also be designed to aid the surgical guide assembly.Meanwhile, a physical anatomical diagnostic model is manufactured byrapid prototyping or CNC milling (See steps 811-812), and idealosteotomies are simulated on the physical anatomical diagnostic model bya qualified clinician (Step 813). Alternatively, the modified anatomicaldiagnostic model with positioning pins placed into the osteotomies canbe digitized by surface scanning (Step 814), and the drill guide 200,400 or 700 may be designed on the modified digital anatomical diagnosticmodel. If bone reduction is planned on a physical anatomical diagnosticmodel then the doctor can drill the ideal osteotomies into the physicalmodel, (See step 813 b).

After all the parts are designed on the digital diagnostic model, theyare manufactured by rapid prototyping such as 3D printing andstereolithography or CNC milling 804, cleaned, inspected, and verifiedon the physical anatomical model 805. Place the base frame and the drillguide housing frame 200 on the physical anatomical model 100, as shownin step 806.

If the drill guide housing frame has skirted areas 301 (FIG. 3B) overthe surgical site, drill holes may be placed through the skirted areas301 with a hand piece 306 (FIG. 3C) so that the holes correspond withthe planned osteotomies. Since the drill guide housing frame is usuallymade with a transparent or semi-transparent material, the simulatedosteotomies on the model is visible thorough the thin skirted areas 301,and corresponding holes can be made. Positioning pins 308 may beinserted into the osteotomies on the anatomical model through the holesof the skirted areas 808. Drill guide bushings 309 may be placed withrespect to the positioning pins 308 and the bushings' distance may beset from the oral structure according to the preference. As brieflydescribed above, the top or the bottom of the skirted areas 301 may beset at, below or above the gum tissue surface 102.

Alternatively, the bottom of the skirted areas 301 may be made tocontact the exposed bone. If the diameter of holes on the skirt is closeto the inner diameter of the drill guide bushing, the bushing can reston the skirted areas. The holes of the skirted areas 301 may also bemade larger so that extra parts to control the height can be insertedonto the positioning pins 305. It should also be noted that the drillguide housing frame 300 may be configured to accommodate various typesof interchangeable drill guide bushings as well as most of depth controlsurgical guide system parts sold by various implant companies. After thepositions are set, the bushings maybe attached to the drill guidehousing frame with light cured composite or other adhesive materials809. Additional light cured composite may be added to the frame toincrease the rigidity of the device. Light cured composite may be addedaround the positioning pins on the skirted areas 301 instead of bushingsto conform drill guide holes or slots. When finished, the positioningpins may be removed from the physical anatomical model 810. The skirtedarea can be then trimmed by a hand piece as previously described.Additional drill guide frames, if any, can be made by repeating theprocess. With a model based implant placement system, it may also bepossible to manually create a surgical drill guide that clasps the gumtissue and the jawbone with similar features without any digitallydesigned frame structures. It should be noted that the skirted area maynot be necessary if the anatomical diagnostic model is surface scannedafter the doctor drills the osteotomies, and the apparatus is designedon the modified digital model.

FIG. 14 illustrates a flowchart of digital surgical planning. When theimplant placement is planned digitally on an aligned digital anatomicaldiagnostic model 902 as illustrated in FIG. 14, the creation of physicalanatomical diagnostic model may be optional. In this case, thetechnician can design the drill guide housing frame according to thesimulated osteotomies on the digital anatomical model. Thus, there maybe no need to create any skirted area. The support structure andreceptor sites for the drill guide bushings can be digitally designed903 so that the device is ready to receive the parts after prototyping.If any drill guide bushing parts with depth control function are goingto be used, the device can be designed to receive those parts at theexact locations to accommodate the function. If the jaw bone 101 isreduced on the digital anatomical diagnostic model, the base frame 200may be designed to function as a bone reduction jig.

Similar to the method for a model based implant placement system, thedrill guide housing frame 300 is manufactured, along with the base frameand other additional frames and accessories, by rapid prototyping or CNCmilling 905. After cleaning and inspection 906, the preferred drillguide bushings 309 can be placed into the drill guide frame 300 andsecured by light cured composite or other adhesive material. For sometype of drill guide bushings (309) adhesives may not be needed. Thedrill guide may also be created with built-in drill guide holes or slotswithout any separate parts if the device is made of an appropriateharder material such as metal.

FIG. 15 illustrates a flowchart of how the apparatus 401 can be utilized1000 during an implant placement surgery. It will be appreciated thatthe steps can be modified, yet remain within the spirit of the exemplaryembodiments herein. It should be noted that there are many variations tothe workflow, and this chart is not intended to teach the surgicalprocedure itself. As is the case with the explanation of diagrams inFIG. 13 and FIG. 14, the following explanation is directed to a multiplepiece drill guide system 401.

Prior to the surgery, all the parts of the drill guide set 401 areproperly sanitized according to the material's requirement. For example,if the parts are rapid prototyped with resin, cold sterilization methodsmay be appropriate. However, heat sterilization may be used fordifferent materials with high temperature tolerance 1001. Lay a partialflap of the patient's gum tissue to expose the jawbone in the area ofinterest 1002. In rare occasions, the surgeon may choose to flap onlythe areas that the bone clasping contact portions of the devise willcontact with, leaving the gum tissue over the implant sites. The baseframe 200 or the single piece surgical drill guide 300 may be securelyplaced on the oral structure 100 and in contact with both gum tissue andthe exposed bone (See steps 1003 and 1003 b). Additional attachments maybe added to the device for bone clasping. Depending on the patient'soral structure, anchor screws or pins may be used for securing theposition of the device. Bone adjustment or bone grafting may be donebefore or after the placement of the base frame 200. If the boneadjustment is needed, the base frame may be used as a jig or anadditional bone adjustment jig can be attached to the base frame 200 forthis process.

Optionally, a modified denture duplicate attachment 500 (FIG. 5) can beused on the base frame 200. In that case, verify the device'spositioning with bite to secure the base frame 200 to the oralstructure, and then remove the attachment portion, leaving the baseframe 300 on the oral structure 1009 and 1010.

After the base frame is securely placed, attach the drill guide section300 to the base frame 200 (step 1004) in order to drill osteotomies intothe jawbone (step 1005). The interchangeable additional drill guidesections may be used to complete the osteotomies 1011. When finished,the drill guide section 400 may be removed from the base frame (200),and the implants may be placed into the jawbone (see step 1006). Shoulda certain type of surgical guide tube system be adopted into the drillguide frame 300, the surgeon may place the implants through the drillguide tube bushings 1009 prior to the removal of the drill guide section400.

The surgeon may choose to take a fixture level index for the record ofimplant positions at this point. In that case, he/she may be able to doso by altering the surgical guide section 400 into a transfer jig trayor by using a separate transfer jig tray that attaches to the base frame200 (See step 1012). One advantage of utilizing the drill guide section400 is that the actual positioning information can be easily transferredback to the physical anatomical model. The model can be adjusted, ifnecessary, and the prosthesis can be created on it without making aseparate brand new model.

After the base frame is removed 1007 the surgeon can complete thesurgery by placing cover screws or healing caps, and suturing the gumtissue over the cover screw or around the healing caps. Alternatively,the immediate loading procedure may be followed, and the prosthesis thathad been designed on the digital or the physical anatomical model can beplaced 1008.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A dental tray set comprising: a base framecontaining surface information of at least one of a gum tissue area anda bone structure of a patient, the base frame being operable to engageat least one of the gum tissue area and the bone structure, the baseframe further having an exterior surface; and at least one surgicalguide section having an exterior surface that extends over at least aportion of the exterior surface of the base frame, and that isattachable to the base frame; wherein the combination of the base frameand the at least one surgical guide section engage the at least one ofthe gum tissue area and the bone structure; and wherein the base frameincludes two spaced-apart base portions, at least one arm disposedtherebetween, and at least one stabilizing arm distinct from the atleast one arm extending from the base frame, the at least onestabilizing arm having a plurality of laterally spaced contact points,at least one of the plurality of laterally spaced contact pointspositioned and configured to contact the at least one of the gum tissuearea and the bone structure.
 2. The dental tray set as claimed in claim1, the tray being configured to receive a patient's jaw including atleast a portion of the bone structure.
 3. The dental tray set as claimedin claim 1, the tray being configured to receive a patient's gum tissue.4. The dental tray set as claimed in claim 1, wherein the exteriorsurface of the at least one surgical guide section includes anattachment member, wherein the exterior surface of the base frameincludes an interlocking connector with an exterior profile that isoperable to receive the attachment member of the at least one surgicalguide section.
 5. The dental tray set as claimed in claim 1, wherein theat least one stabilizing arm comprises two stabilizing arms, each of thetwo stabilizing arms extending from each of the base portions andterminating at a free end.
 6. The dental tray as claimed in claim 1,wherein the at least one stabilizing arm is pliable and operable toexert an inwardly facing force by way of the plurality of contact pointsupon the at least one of the gum tissue area and the bone structure. 7.The dental tray set as claimed in claim 1, wherein the at least onesurgical guide section comprises at least two surgical guide sections,an intended osteotomy being associated with each of the at least twosurgical guide sections such that the intended osteotomies havingintersecting positioning angulations.
 8. The dental tray set as claimedin claim 1, wherein the at least one surgical guide section includesguides for directing a surgical hand piece to create an osteotomy into apatient's jawbone.
 9. The dental tray set as claimed in claim 1, whereinthe at least one surgical guide section has at least one drill guide todrill at least one osteotomy into a patient's jawbone.
 10. The dentaltray set as claimed in claim 1, further comprising at least onedetachably attachable appliance that is attachable either to the baseframe or to the at least one surgical guide section, the at least onedetachably attachable appliance being selected from the group consistingof an implant transfer attachment, an implant pickup coping tray, a boneadjustment jig, and a modified duplicated denture tray.
 11. The dentaltray set as claimed in claim 10, wherein the at least one detachablyattachable appliance comprises a plurality of detachably attachableappliances, which may be attachable to the same base frame or at leastone surgical guide section.
 12. The dental tray set as claimed in claim1, wherein the dental tray set is operable to be mounted to both a modelof a patient's mouth and a patient's mouth, the tray being selectivelyadjusted when mounted to the model to facilitate being mounted to thepatient's mouth.
 13. The dental tray as claimed in claim 1, wherein theat least one surgical guide section includes two spaced-apart guideportions, an arm disposed therebetween, the spaced-apart guide portionsand the at least one arm of the guide section overlap with and engagethe spaced-apart base portions and the at least one arm of the baseframe by way of a plurality of interlocking connectors.
 14. The dentalframe as claimed in claim 1, wherein points of non-contact are definedbetween adjacent ones of the plurality of laterally spaced contactpoints.
 15. The dental tray set as claimed in claim 1, wherein the baseframe works as a bone reduction jig.
 16. The dental tray set as claimedin claim 1, wherein at least one of the base frame and the at least onesurgical guide section are formed from at least one of a resin, anacrylic, a thermoplastic, a metal and a composite material.
 17. A dentaltray set comprising: a base frame, the base frame having an exteriorgeometry with an exterior surface that is configured from a model of apatient's mouth, the base frame including two spaced apart baseportions, at least one arm disposed between the two spaced apartportions and having at least first lateral contact area disposed alongan inward surface for contacting the lingual side of a dental arch, atleast one stabilizing arm distinct from the at least one arm extendingfrom the base portions and having at least a second lateral contact areadisposed along an inward surface for contacting the facial side of adental arch, at least one of the at least one arm and the at least onestabilizing arm connected to both of the two spaced apart base portions,an open space defined by the inward surface of each of the at least onearm and the at least ene stabilizing arm and the base portions forallowing an open view of a potential surgical site; and at least onesurgical guide section with an exterior surface that is positionableover the corresponding exterior surface of the base frame, and that isdetachably attachable to the base frame.
 18. The dental tray set asclaimed in claim 17, wherein the base frame is configured to receive atleast one of a bone and gum tissue.
 19. The dental tray set as claimedin claim 17, wherein at least one of the at least one arm and the atleast one stabilizing arm are pliable and operable to exert an inwardlyfacing force by way of a plurality of contact points disposed along theinward surface.
 20. The dental tray set as claimed in claim 17, whereinthe at least onq surgical guide section includes spaced apartinterlocking connectors connectable to the base frame.
 21. The dentaltray set as claimed in claim 17, wherein the at least one surgical guidesection has at least one drill guide to drill at least one osteotomyinto a patient's jawbone by way of the potential surgical site.
 22. Thedental tray set as claimed in claim 17, further comprising at least Onedetachably attachable appliance that is attachable either to the baseframe or the at least one surgical guide section, the at least onedetachably attachable appliance being selected from the group consistingof an implant transfer attachment, an implant pickup coping tray, a boneadjustment jig, and a modified duplicated denture tray, and wherein theat least one detachably attachable appliance includes a plurality ofdetachably attachable appliances that may be attachable to the same baseframe or the at least one surgical guide section.
 23. The dental trayset as claimed in claim 17, wherein the at least one surgical Guidesection comprises two surgical guide sections, an intended osteotomybeing associated with each of the two surgical guide sections such thatthe intended osteotomies having intersecting positioning angulations.24. The dental tray set as claimed in claim 17, wherein the model of apatient's mouth is at least one of an anatomical model of a patient'sjaw, a surface model of a patient's oral structure, and a bottom surfacemodel of a patient's existing prosthesis.
 25. The dental tray set asclaimed in claim 17, wherein the base frame works as a bone reductionjig.
 26. The dental tray set as claimed in claim 17, wherein at leastone of the base frame and the at least one surgical guide section areformed from at least one of a resin, an acrylic, a thermoplastic, ametal and a composite material.